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Stopping Tyrosine Kinase Inhibitors in Affecting Treatment-Free Remission in Patients with Chronic Phase Chronic Myeloid Leukemia

Trial Status: Active

This phase II trial studies how stopping tyrosine kinase inhibitors will affect treatment-free remission in patients with chronic myeloid leukemia in chronic phase. When the level of disease is very low, it's called molecular remission. TKIs are a type of medication that help keep this level low. However, after being in molecular remission for a specific amount of time, it may not be necessary to take tyrosine kinase inhibitors. It is not yet known whether stopping tyrosine kinase inhibitors will help patients with chronic myeloid leukemia in chronic phase continue or re-achieve molecular remission.

Inclusion Criteria

  • Patient must have been diagnosed with CML-CP at < 18 years of age.
  • Patient must have histologic verification of CML-CP at original diagnosis
  • Patient must be in molecular remission (MR) with a BCR-ABL1 level of =< 0.01% BCR-ABL1 as measured using the International Scale (IS) by RQ-PCR for >= 2 consecutive years at the time of enrollment * Please note: The lab evaluating disease status and molecular response for this study must be College of American Pathology (CAP) and/or Clinical Laboratory Improvement Amendments (CLIA) certified (United States [US] only), sites in other countries must be certified by their accredited authorities. All labs must use the International Scale guidelines with a sensitivity of detection assay =< 0.01% BCR-ABL1 and be able to report results in =< 2 weeks
  • Patient must have received any TKI for a minimum of 3 consecutive years at time of enrollment
  • Patient agrees to discontinue TKI therapy
  • REGULATORY REQUIREMENTS
  • All patients and/or their parents or legal guardians must sign a written informed consent
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
  • ELIGIBILITY FOR PATIENT-REPORTED OUTCOMES (PROs):
  • Age >= 8 years at the time of enrollment
  • Ability to understand English or Spanish
  • Cognitive ability to complete instruments according to the primary team
  • ELIGIBILITY FOR AAML18P1 NEUROCOGNITIVE STUDY:
  • Patient must be 5 years or older at the time of enrollment
  • English-, French- or Spanish-speaking
  • No known history of neurodevelopmental disorder prior to diagnosis of CML (e.g., Down syndrome, Fragile X, William syndrome, mental retardation)
  • No significant visual or motor impairment that would prevent computer use or recognition of visual test stimuli

Exclusion Criteria

  • Known T3151 mutation
  • Additional clonal chromosomal abnormalities in Philadelphia chromosome (Ph) positive (+) cells at any time prior to enrollment that include “major route” abnormalities (second Ph, trisomy 8, isochromosome 17q, trisomy 19), complex karyotype or abnormalities of 3q26.2
  • History of accelerated phase or blast crisis CML
  • Female patients who are pregnant
  • Lactating females are not eligible unless they have agreed not to breastfeed their infants
  • Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained

Alabama

Birmingham
Children's Hospital of Alabama
Status: ACTIVE
Contact: Site Public Contact
Phone: 205-638-9285

Arizona

Mesa
Banner Children's at Desert
Status: ACTIVE
Contact: Site Public Contact
Phone: 480-412-3100

Arkansas

Little Rock
Arkansas Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 501-364-7373

California

Downey
Kaiser Permanente Downey Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 626-564-3455
Long Beach
Miller Children's and Women's Hospital Long Beach
Status: ACTIVE
Contact: Site Public Contact
Phone: 562-933-5600
Los Angeles
Children's Hospital Los Angeles
Status: ACTIVE
Contact: Site Public Contact
Phone: 323-361-4110
Mattel Children's Hospital UCLA
Status: ACTIVE
Contact: Site Public Contact
Phone: 310-825-6708
Madera
Valley Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 559-353-3000
Oakland
Kaiser Permanente-Oakland
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Palo Alto
Lucile Packard Children's Hospital Stanford University
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-694-0012
Sacramento
University of California Davis Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 916-734-3089

Colorado

Aurora
Children's Hospital Colorado
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-764-5056
Denver
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-839-6000

Connecticut

Hartford
Connecticut Children's Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 860-545-9981

Delaware

Wilmington
Alfred I duPont Hospital for Children
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-651-6884

District of Columbia

Washington
Children's National Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 202-884-2549
MedStar Georgetown University Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 202-444-2223

Florida

Fort Myers
Golisano Children's Hospital of Southwest Florida
Status: ACTIVE
Contact: Site Public Contact
Phone: 239-343-5333
Hollywood
Memorial Regional Hospital / Joe DiMaggio Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 954-265-1847
Email: OHR@mhs.net
Jacksonville
Nemours Children's Clinic-Jacksonville
Status: ACTIVE
Contact: Site Public Contact
Phone: 904-697-3529
Miami
Nicklaus Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-624-2778
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 305-243-2647
Orlando
Arnold Palmer Hospital for Children
Status: ACTIVE
Contact: Site Public Contact
Phone: 321-841-2008
Nemours Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 407-650-7715
Pensacola
Sacred Heart Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 850-416-4611
Tampa
Saint Joseph's Hospital / Children's Hospital-Tampa
Status: ACTIVE
Contact: Site Public Contact
Phone: 813-357-0849
Tampa General Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 813-844-7829

Georgia

Atlanta
Children's Healthcare of Atlanta - Egleston
Status: ACTIVE
Contact: Site Public Contact
Phone: 404-785-2025
Savannah
Memorial Health University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 912-350-7887

Hawaii

Honolulu
Kapiolani Medical Center for Women and Children
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-983-6090

Idaho

Boise
Saint Luke's Cancer Institute - Boise
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-2774

Illinois

Chicago
Lurie Children's Hospital-Chicago
Status: ACTIVE
Contact: Site Public Contact
Phone: 773-880-4562
University of Chicago Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 773-702-8222
University of Illinois
Status: ACTIVE
Contact: Site Public Contact
Phone: 312-355-3046
Maywood
Loyola University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 708-226-4357
Oak Lawn
Advocate Children's Hospital-Oak Lawn
Status: ACTIVE
Contact: Site Public Contact
Phone: 847-723-7570
Park Ridge
Advocate Children's Hospital-Park Ridge
Status: ACTIVE
Contact: Site Public Contact
Peoria
Saint Jude Midwest Affiliate
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-226-4343
Springfield
Southern Illinois University School of Medicine
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-545-7929

Indiana

Indianapolis
Riley Hospital for Children
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-248-1199

Iowa

Des Moines
Blank Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-241-8912
Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-237-1225

Kentucky

Lexington
University of Kentucky / Markey Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 859-257-3379
Louisville
Norton Children's Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 502-629-5500

Louisiana

New Orleans
Ochsner Medical Center Jefferson
Status: ACTIVE
Contact: Site Public Contact
Phone: 504-842-8084

Maine

Bangor
Eastern Maine Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 207-973-4274
Scarborough
Maine Children's Cancer Program
Status: ACTIVE
Contact: Site Public Contact
Phone: 207-396-7581

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 410-955-8804
Sinai Hospital of Baltimore
Status: ACTIVE
Contact: Site Public Contact
Phone: 410-601-6120
Bethesda
Walter Reed National Military Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 301-319-2100

Massachusetts

Boston
Dana-Farber Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-442-3324
Worcester
UMass Memorial Medical Center - University Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 508-856-3216

Michigan

Ann Arbor
C S Mott Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-865-1125
Detroit
Wayne State University / Karmanos Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-576-9790
East Lansing
Michigan State University Clinical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 517-975-9547
Grand Rapids
Helen DeVos Children's Hospital at Spectrum Health
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Kalamazoo
Bronson Methodist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Royal Oak
Beaumont Children's Hospital-Royal Oak
Status: ACTIVE
Contact: Site Public Contact
Phone: 248-551-7695

Minnesota

Minneapolis
Children's Hospitals and Clinics of Minnesota - Minneapolis
Status: ACTIVE
Contact: Site Public Contact
Phone: 612-813-5193

Mississippi

Jackson
University of Mississippi Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 601-815-6700

Missouri

Columbia
Columbia Regional
Status: ACTIVE
Contact: Site Public Contact
Kansas City
Children's Mercy Hospitals and Clinics
Status: ACTIVE
Contact: Site Public Contact
Phone: 816-302-6808
Email: rryan@cmh.edu
Saint Louis
Mercy Hospital Saint Louis
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-251-7066
Washington University School of Medicine
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606

Nebraska

Omaha
Children's Hospital and Medical Center of Omaha
Status: ACTIVE
Contact: Site Public Contact
Phone: 402-955-3949
University of Nebraska Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 402-559-6941

Nevada

Las Vegas
Alliance for Childhood Diseases / Cure 4 the Kids Foundation
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Summerlin Hospital Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Sunrise Hospital and Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
University Medical Center of Southern Nevada
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Reno
Renown Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013

New Jersey

Hackensack
Hackensack University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 201-996-2879
New Brunswick
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 732-235-8675
Paterson
Saint Joseph's Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 973-754-2207

New York

Albany
Albany Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 518-262-5513
Buffalo
Roswell Park Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-767-9355
Mineola
NYU Winthrop Hospital
Status: ACTIVE
Contact: Site Public Contact
New Hyde Park
The Steven and Alexandra Cohen Children's Medical Center of New York
Status: ACTIVE
Contact: Site Public Contact
Phone: 718-470-3460
New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-305-6361
NYP / Weill Cornell Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-746-1848
Rochester
University of Rochester
Status: ACTIVE
Contact: Site Public Contact
Phone: 585-275-5830
Stony Brook
Stony Brook University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-862-2215
Syracuse
State University of New York Upstate Medical University
Status: ACTIVE
Contact: Site Public Contact
Phone: 315-464-5476
Valhalla
New York Medical College
Status: ACTIVE
Contact: Site Public Contact
Phone: 914-594-3794

North Carolina

Asheville
Mission Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 828-213-7055
Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-668-0683
Charlotte
Carolinas Medical Center / Levine Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-804-9376
Greenville
East Carolina University
Status: ACTIVE
Contact: Site Public Contact
Phone: 252-744-1015
Winston-Salem
Wake Forest University Health Sciences
Status: ACTIVE
Contact: Site Public Contact
Phone: 336-713-6771

North Dakota

Fargo
Sanford Broadway Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 701-323-5760

Ohio

Akron
Children's Hospital Medical Center of Akron
Status: ACTIVE
Contact: Site Public Contact
Phone: 330-543-3193
Cleveland
Cleveland Clinic Foundation
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-223-8100
Rainbow Babies and Childrens Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 216-844-5437
Columbus
Nationwide Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-072-2657
Dayton
Dayton Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-228-4055
Toledo
ProMedica Toledo Hospital / Russell J Ebeid Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 419-824-1842

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 405-271-8777

Oregon

Portland
Legacy Emanuel Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-413-2560
Oregon Health and Science University
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-494-1080

Pennsylvania

Allentown
Lehigh Valley Hospital-Cedar Crest
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Danville
Geisinger Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-271-5251
Hershey
Penn State Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 717-531-6012
Philadelphia
Children's Hospital of Philadelphia
Status: ACTIVE
Contact: Site Public Contact
Phone: 267-425-5544
Saint Christopher's Hospital for Children
Status: ACTIVE
Contact: Site Public Contact
Phone: 215-427-8991
Pittsburgh
Children's Hospital of Pittsburgh of UPMC
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-692-8570

Puerto Rico

Caguas
HIMA San Pablo Oncologic Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 787-653-3434

Rhode Island

Providence
Rhode Island Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 401-444-1488

South Carolina

Columbia
Prisma Health Richland Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-241-6251
Greenville
BI-LO Charities Children's Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-241-6251

South Dakota

Sioux Falls
Sanford USD Medical Center - Sioux Falls
Status: ACTIVE
Contact: Site Public Contact
Phone: 605-312-3320

Tennessee

Chattanooga
T C Thompson Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 865-331-1812
Knoxville
East Tennessee Childrens Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 865-541-8266
Memphis
Saint Jude Children's Research Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-226-4343
Nashville
The Children's Hospital at TriStar Centennial
Status: ACTIVE
Contact: Site Public Contact
Phone: 615-342-1919

Texas

Amarillo
Texas Tech University Health Sciences Center-Amarillo
Status: ACTIVE
Contact: Site Public Contact
Phone: 806-354-5411
Austin
Dell Children's Medical Center of Central Texas
Status: ACTIVE
Contact: Site Public Contact
Phone: 512-628-1902
Dallas
Medical City Dallas Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 972-566-5588
UT Southwestern / Simmons Cancer Center-Dallas
Status: ACTIVE
Contact: Site Public Contact
Phone: 214-648-7097
El Paso
El Paso Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 915-298-5444
Houston
Baylor College of Medicine / Dan L Duncan Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 713-798-1354
M D Anderson Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-632-6789
Lubbock
Covenant Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
UMC Cancer Center / UMC Health System
Status: ACTIVE
Contact: Site Public Contact
Phone: 806-775-8590
San Antonio
Children's Hospital of San Antonio
Status: ACTIVE
Contact: Site Public Contact
Methodist Children's Hospital of South Texas
Status: ACTIVE
Contact: Site Public Contact
Phone: 210-575-6240
University of Texas Health Science Center at San Antonio
Status: ACTIVE
Contact: Site Public Contact
Phone: 210-450-3800

Utah

Salt Lake City
Primary Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 801-585-5270

Virginia

Falls Church
Inova Fairfax Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 703-208-6650
Norfolk
Children's Hospital of The King's Daughters
Status: ACTIVE
Contact: Site Public Contact
Phone: 757-668-7243
Richmond
Virginia Commonwealth University / Massey Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Roanoke
Carilion Children's
Status: ACTIVE
Contact: Site Public Contact
Phone: 540-266-6238

Washington

Seattle
Seattle Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-987-2000
Spokane
Providence Sacred Heart Medical Center and Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-228-6618
Tacoma
Madigan Army Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 253-968-0129
Mary Bridge Children's Hospital and Health Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 253-403-1461

West Virginia

Charleston
West Virginia University Charleston Division
Status: ACTIVE
Contact: Site Public Contact
Phone: 304-388-9944

Wisconsin

Madison
University of Wisconsin Hospital and Clinics
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-622-8922
Marshfield
Marshfield Medical Center-Marshfield
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581

Manitoba

Winnipeg
CancerCare Manitoba
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-561-1026

Nova Scotia

Halifax
IWK Health Centre
Status: ACTIVE
Contact: Site Public Contact
Phone: 902-470-8037

Ontario

Hamilton
McMaster Children's Hospital at Hamilton Health Sciences
Status: ACTIVE
Contact: Site Public Contact
Phone: 905-521-2100
Ottawa
Children's Hospital of Eastern Ontario
Status: ACTIVE
Contact: Site Public Contact
Phone: 613-738-3931
Toronto
Hospital for Sick Children
Status: ACTIVE
Contact: Site Public Contact
Phone: 416-813-7654

Quebec

Montreal
Centre Hospitalier Universitaire Sainte-Justine
Status: ACTIVE
Contact: Site Public Contact
Phone: 514-345-4931
The Montreal Children's Hospital of the MUHC
Status: ACTIVE
Contact: Site Public Contact
Phone: 514-412-4445
Quebec
Centre Hospitalier Universitaire de Quebec
Status: ACTIVE
Contact: Site Public Contact
Phone: 418-525-4444

Australia

Clayton
Monash Medical Center-Clayton Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: (03) 9928 8111
Perth
Perth Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Westmead
The Children's Hospital at Westmead
Status: ACTIVE
Contact: Site Public Contact
Phone: 61-2-9845 1400

PRIMARY OBJECTIVES:

I. To determine the 2-year treatment free remission (TFR) rate of children, adolescents, and young adults with chronic myeloid leukemia - chronic phase (CML-CP) following discontinuation tyrosine kinase inhibitor (TKI).

II. To estimate the re-induction rate and maintenance of molecular remission (BCR-ABL1 =< 0.1%) at 1 year after restarting TKI for children, adolescents, and young adults.

SECONDARY OBJECTIVE:

I. To describe clinical factors and laboratory correlates affecting the persistence of major molecular remission (MMR) and re-initiation of treatment after stopping TKI (e.g. patient demographics, duration and level of prior molecular remission, duration and type of TKI, clinical presentation at diagnosis and immune studies).

EXPLORATORY OBJECTIVES:

I. To describe change in height standard deviation score over time in patients who are able to discontinue their TKI.

II. To describe the long-term health outcomes including but not limited to gonadal function, endocrine function, and bone metabolism in patients who are able to discontinue TKI as well as those that need to restart TKIs.

III. To describe differences in patient-reported health status after stopping TKIs, including those who need to resume TKI after stopping.

IV. To describe the incidence and characteristics of TKI withdrawal syndrome in children.

V. To evaluate changes in neurocognitive outcomes of patients enrolled on this study using a patient-completed, performance-based, computerized measure of neuropsychological functioning and a parent-report/self-report questionnaire.

OUTLINE:

Patients stop taking TKI medication within 10 days after enrollment. Patients undergo peripheral blood collection to monitor loss of MMR every 4 weeks in year 1, every 6 weeks in year 2, and every 12 weeks in year 3. Patients who lose their molecular remission may restart TKI medication and are monitored every 4 weeks in year 1, every 6 weeks in year 2, and every 12 weeks in year 3.

After completion of study treatment, patients are followed up annually.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Children's Oncology Group

Principal Investigator
Sonali Chaudhury

  • Primary ID AAML18P1
  • Secondary IDs NCI-2018-03439
  • Clinicaltrials.gov ID NCT03817398